SAD Study in Patients With Parkinson's Disease and Motor Fluctuations
← catalyst calendarNCT07422675 · readout in 165 d
Sponsored by Serina Therapeutics (industry) · SER — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
40estimated
Sites
6
Countries
Australia, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-01 | actual | When the study began enrolling |
| Primary completion | 2027-01-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-31 | estimated | The whole study's end, after follow-up |
| First posted | 2026-02-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- PARKINSON DISEASE (Disorder)
- Advanced Parkinson's Disease
Interventions
- Drug: SER-252 (PEOZ-apomorphine)
- Device: enFuse
Primary outcomes
what the primary-completion date above is the date OFIncidence and Temporal Profile of Treatment-Emergent Adverse Events (TEAEs)
measured From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).
Incidence of Moderate or Severe TEAEs Related to Study Intervention
measured From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).
Incidence of Serious Adverse Events (SAEs), including suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
measured From first dose through Day 44 (30 days after the Day 14 end-of-participation visit).
Change from Baseline in Vital Signs
measured Baseline to Day 8 (with Day 14 follow-up vitals also collected)
Area under the concentration-time curve (AUC0-24, AUC0-96, AUC0-∞)
measured Day 1 through Day 8 (0-168 hours post-dose)
Change from Baseline in Corrected QT Interval (QTcF)
measured Baseline to Day 8 (with Day 14 safety follow-up ECGs).
Time to Maximum Plasma Concentration (Tmax)
measured Day 1 through Day 8 (0-168 hours post-dose).
Change from Baseline in Clinical Laboratory Parameters
measured Baseline to Day 8 (laboratories at safety follow-up only if needed to follow up abnormalities).
Fluctuation Index (FI)
measured Day 1 through Day 8 (0-168 hours)
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
measured Screening/Day -1 and Day 8.
Trough Concentration (Ctrough)
measured Days 2-8 (24-168 hours post-dose).
Coefficient of Variation (CV%) for Exposure
measured Day 1 through Day 8 (0-168 hours).
Distributional Half-Life (h)
measured Day 1 through Day 8
Maximum Plasma Concentration (Cmax)
measured Day 1 through Day 8 (0-168 hours post-dose)
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